FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRA HIGH PRESSURE INJECTOR LINES
K Number: K023591
·
Decision Jun 18, 2003
Classifications
1
FEI Numbers
213
Registration Numbers
214
Same Product Code
497
Applicant Total
82
Review Days
236
Basic Information
- Device Name
- ULTRA HIGH PRESSURE INJECTOR LINES
- K Number
- K023591
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DEROYAL INDUSTRIES, INC.
- Date Received
- October 25, 2002
- Decision Date
- June 18, 2003
- Product Code
- DQO
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQO), ordered by most recent decision date.
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
pNOVUS 21 Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Impress Angiographic Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Zoom 6F Insert Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
Soldier Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
INFINITI Ambi Angiographic Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by DEROYAL INDUSTRIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K152978 | DeRoyal Angiography Kits | Mar 25, 2016 | Unknown |
| K131292 | DEROYAL SPINE SPACER SYSTEM | Feb 3, 2014 | Substantially Equivalent |
| K132199 | DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST | Oct 3, 2013 | Substantially Equivalent |
| K090975 | DEROYAL NON-LOCKING BONE FIXATION SYSTEM | Apr 12, 2010 | Substantially Equivalent |
| K092317 | DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM | Nov 2, 2009 | Substantially Equivalent |
| K030365 | DEROYAL DRAPES, STERILE, NON-STERILE | Apr 29, 2003 | Substantially Equivalent |
| K030364 | DEROYAL GOWNS, STERILE, NON-STERILE | Apr 28, 2003 | Substantially Equivalent |
| K991525 | DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF | Jul 20, 1999 | Substantially Equivalent |
| K983750 | DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER | Nov 30, 1998 | Substantially Equivalent |
| K982465 | DEROYAL INDUSTRIES, INC. DEFOGGER | Aug 11, 1998 | Substantially Equivalent |